SwissMedic: New "Submissions" division started to process

The New "Submissions" division began its activities on 3 January 2012, and has led to various changes within internal responsibilities. On the long term, the division will take over as the central reception point for all correspondence regarding Swissmedic's service processes (authorisation, market surveillance, licences), handle the triage, registration and formal and technical control, and then forward it to the corresponding expert units within Swissmedic. In doing so, the processing of applications will be structured even more efficiently.

The previous address remains unchanged. General questions regarding the submission of applications can, as before, be sent via the contact form on the Swissmedic website. Questions regarding eSubmissions should still be sent to esubmission@swissmedic.ch.

Source: http://www.swissmedic.ch/zulassungen/00173/01901/index.html?lang=en

American Medical Writers Association (AMWA) : Good/Bad Authoring Practices and the Impact on the eCTD Quality and Compliance - Presentation - By Antoinette Azevedo, President, e-SubmissionsSolutions

The detailed presentation covered the following information (or) topics. 

• Introductions & expectations

• What is eCTD & why are we discussing this topic?

• What can go wrong with eCTD and how can the medical writer save us?

• How medical writers can assure compliance of PDF files

• eCTD best practices

• eCTD workflow

To find the presentation slide deck click here 

http://www.box.com/s/33eat7v001nud46csi59

CMDh meeting with representatives of Interested Parties - Meeting - E-submissions – Technical Validation

The RMS-led technical validation as the main point. CMSs will rely on the technical validation done by the RMS. Applicants need to check CDs/DVDs for readability to identify burning problems. It was noted that in general, problems with technical validation seem to decline.

 The timelines for technical validation and the use of CTS are still subject to further discussion within the CMDh. It was stressed that the changed procedure should apply to eCTD and NeeS. There will also be further discussion on the submission date for technical validation with regard to data exclusivity.

 Applicants are encouraged to technically validate their submissions in advance with the appropriate and publicly available validation tools. A technical validation by the applicant on behalf of the RMS will not yet be an option. The intention is to extend the procedure to all submission types after successful implementation for new MAAs.

To find more information please click here

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/About_CMDh/Contact_with_Representatives_Organisations/Meeting_IP_Nov_2011/November_2011-CMDh_Meeting_with_IP-Minutes.pdf

US FDA re-issues PDF Spec V3.1 to clarify language on acceptable PDF versions for documents, add page numbers

FDA re-issues PDF Spec V3.1 to clarify language on acceptable PDF versions for documents, add page number.

To find the updated PDF specification document please use the below link

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf

Drug Information Journal (DIJ): The Electronic Common Technical Document (eCTD) : An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process - By Andreas Suchanek and Prof.Herwig Ostermann, PhD.

The International Conference on Harmonization’s electronic Common Technical Document (eCTD) endeavors to significantly change the pharmaceutical submission process. After decades of using paper, the goal is the electronic transfer of drug applications and their review across submission formats, procedures, and regions. However, it is still unclear whether implementing eCTD really brings more advantages than disadvantages and, if so, for what kind of companies. After an expert interview was conducted in 2009, this research study was formed as an international survey officially supported by the European Medicines Agency in 2010. Overall, 963 responses were received, and 397 were used for the subsequent study analysis. Although a three-fourths majority of those with eCTD experience reported disadvantages in implementing eCTD, an overwhelming majority of the same group reported advantages that outweighed the disadvantages, some of them significantly. More than three-quarters of individuals with eCTD experience were able to shorten their total time to approval, and more than 90% of this group was able to demonstrate cost savings relative to paper submissions, regardless of their company kind, size, or number of submissions.

To find the article please use the below mentioned weblink

http://dij.sagepub.com/content/46/1/124.full.pdf+html